Sepsis Clinical Trial
Official title:
Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients
Verified date | February 2021 |
Source | Sohag University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.
Status | Completed |
Enrollment | 67 |
Est. completion date | December 28, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | Inclusion Criteria: - Temperature of >38oC - Heart rate of >90 beats/min - Respiratory rate of >20 breaths/min - Partial pressure of arterial carbon dioxide (PaCO2) of <32 mmHg - White blood cell (WBC) count of >12,000 cells/mm3 Exclusion Criteria: - HIV patients - Patients with neutropenia <1000 cells/mm3 - <18 years of age. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine - sohag university | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS | by ELISA"enzyme linked immunosorbent assay" | in the 1st day after appearance of clinical signs of infection | |
Primary | Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS | by ELISA"enzyme linked immunosorbent assay" | in the 7th day after appearance of clinical signs of infection | |
Primary | Measurement of the serum level of sUPAR (ng/L) in the ICU patients | by ELISA"enzyme linked immunosorbent assay" | in the 1st day after appearance of clinical signs of infection | |
Primary | Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS | by ELISA"enzyme linked immunosorbent assay" | in the 7th day after appearance of clinical signs of infection | |
Primary | Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS | by turbidimetry | in the 1st day after appearance of clinical signs of infection | |
Primary | Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS | by turbidimetry | in the 7th day after appearance of clinical signs of infection | |
Secondary | Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS | an integer score from 0 to 71 | in the 7th day after appearance of clinical signs of infection | |
Secondary | The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS | 0-<11 | in the 7th day after appearance of clinical signs of infection |
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